Respective potencies of Botox and Dysport in a human skin model: a randomized, double-blind study.
Mouse units used to quantify the activity of botulinum A toxin preparations are not equivalent and issues concerning efficacy and safety remain with regard to their respective potencies and diffusion qualities in human tissue. We compared the effects of Botox (BOT) and Dysport (DYS) in different doses and dilutions in a human skin model. Eighteen (8 women, 10 men) healthy volunteers, aged 28.4 years +/- 5.7 years were injected intradermally with pure saline, BOT and DYS at 16 points in the abdomen in random order and in a double-blind condition, using two conversion ratios (1:3 and 1:4) and three different dilution schemes. For an objective outcome, the Ninhydrin sweat test was used to compare the anhidrotic areas. Both preparations showed a linear dose and dilution relationship with similar variances of responses for anhidrosis and hypohidrosis, indicating the same reliability of response. The dose equivalence conversion ratios (BOT: DYS) were 1:1.3 for anhidrosis and 1:1.6 for hypohidrosis (1:1.1-1.5 and 1:1.4-1.8 95% confidence intervals). The diffusion characteristics of both products were similar. A dose equivalence factor of more than 1:2 (BOT:DYS) is not supported by these objective and reproducible data.
Kranz
Gottfried
G
Department of Neurology, Medical University of Vienna, Wien, Austria.
Haubenberger
Dietrich
D
Voller
Bernhard
B
Posch
Martin
M
Schnider
Peter
P
Auff
Eduard
E
Sycha
Thomas
T
D000005:Abdomen; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology*; D004058:Diffusion; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006358:Hot Temperature; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects*; D013546:Sweating / Q000187:drug effects*; D055815:Young Adult
D019274:Botulinum Toxins, Type A